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FDA Drug Application 019677 by MYLAN INSTITUTIONAL

Application Number019677
Application Type New Drug Application
Sponsor ApplicantMYLAN INSTITUTIONAL
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New combination
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/6/1991N       
AP03/20/1992SCM       
AP03/11/1994SCS       
AP012/26/2000SCM       
AP04/18/2002SCS       
AP012/6/2005SLR13261005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019677s005,019678s005lbl.pdf 12/15/2005
AP012/6/2005SLR13276005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019677s005,019678s005ltr.pdf 12/15/2005
AP04/1/2009SCM22204006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019677s006ltr.pdf 4/3/2009
AP04/1/2009SCM22212006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019677s006lbl.pdf 4/3/2009




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